Director, Quality Assurance

Job Description:

As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease.  

As Director, Quality Assurance you will oversee the Quality Assurance function for Ferring manufacturing site in NJ. Champion a culture of quality across the organization by embedding a proactive quality mindset in all aspects of operations. Ensure strict adherence to global regulatory requirements, industry standards, and internal policies. The Director will mitigate quality risks and ensure product quality, patient safety, and regulatory compliance are maintained.  

With Ferring, you will be joining a recognized leader, identified as one of “The World’s Most Innovative Companies” by Fast Company, and honored by Fortune with inclusion on its “Change the World List,” for addressing society’s unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country. 

Responsibilities:  

• Lead and mentor the QA team, fostering accountability, compliance, and continuous improvement.

• Develop and implement strategic plans to meet corporate and local quality objectives.

• Act as a key member of the site leadership team, providing insights on quality and business performance.

• Serve as the liaison between QA and senior management, communicating concerns, resource needs, and action plans.

• Ensure alignment with organizational goals and regulatory requirements, maintaining GxP standards.

• Ensure adherence to GxP standards, manage regulatory inspections, and oversee batch record reviews and product release.

• Oversee the quality system, including deviations, complaints, recalls, change control, and validation.

• Drive continuous improvement by tracking key quality metrics and resolving issues.

• Oversee QA training, ensuring employees are equipped with GMP and necessary skills.

• Collaborate with Production, Development, and Regulatory Affairs to ensure quality integration.

• Lead internal and external audits, ensuring compliance and managing corrective actions.

• Lead or participate in cross-functional quality and compliance projects.

• Manage the QA department budget and resources to achieve departmental goals.

• Provide leadership in addressing emerging quality and regulatory issues.

Requirements:

• Minimum Bachelor’s degree in Life Sciences, Engineering, or related field;

• 10+ years of experience in pharmaceutical manufacturing, including 5+ years in senior QA leadership.

• In-depth knowledge of GxP, FDA regulations, and industry standards.

• Proven expertise in managing quality systems, leading audits, and ensuring regulatory compliance.

• Strong leadership abilities with experience mentoring and developing teams.

• Excellent communication skills for effective interaction with cross-functional teams and senior leadership.

• Expertise in quality systems management, risk management, and CAPA processes.

• Familiar with pharmaceutical manufacturing equipment and processes.

• Certified Lead Auditor (ASQ or ISO) preferred.

• Proficient in MS Office; experience with Veeva, LIMS, and other quality systems preferred.

Physical Requirements:

• Regularly required to sit, talk, and hear in meetings and during documentation review.

• Frequently required to stand and walk particularly during facility walkthroughs, audits, or inspections.

• Must occasionally lift and/or move up to 20 pounds, such as documentation binders, or samples.

• May be exposed to manufacturing environments with elevated noise levels, machinery, and cleanroom protocols.

• Must be able to wear appropriate personal prot